Cancer research and treatment · 2025
Efficacy and Safety of Ropeginterferon Alfa-2b in Low-Risk Polycythemia Vera.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Lee Ji Yun, Yoon Sung-Soo, Yang Deok-Hwan, Sohn Sang Kyun, Yoon Seug Yun, Bang Soo-Mee, Lee Gyeong-Won, Choi Chul Won, Choi Eun-Ji, Cheong June-Won, Park Young Hoon, Lee Sung-Eun
Аннотация
PURPOSE: Conventional management of low-risk polycythemia vera (PV), consisting of phlebotomy and aspirin, often fails to adequately control symptoms and hematologic parameters. This study evaluated the efficacy and safety of ropeginterferon alfa-2b (Ropeg) in low-risk PV patients requiring cytoreductive therapy.
MATERIALS AND METHODS: In this sub-analysis of an open-label, multicenter trial, 42 patients received Ropeg for 48 weeks. The primary endpoint was a reduction in phlebotomy frequency, while secondary endpoints included complete hematologic response (CHR), changes in JAK2V617F allele burden, and safety.
RESULTS: Among 42 patients, Ropeg significantly reduced mean phlebotomy frequency per year from 3.0 to 0.5 (p < 0.05) and improved CHR rates (69.1% at 48 weeks). The JAK2V617F allele burden decreased, and hydroxyurea-naïve patients showed better responses. The most frequently reported treatment-related adverse events included elevated liver enzymes and alopecia. Most adverse events were mild or moderate, with no grade 4 or 5 events reported.
CONCLUSION: These findings suggest that Ropeg is a promising treatment option for low-risk PV by effectively reducing the need for phlebotomy and demonstrating efficacy and safety.
MATERIALS AND METHODS: In this sub-analysis of an open-label, multicenter trial, 42 patients received Ropeg for 48 weeks. The primary endpoint was a reduction in phlebotomy frequency, while secondary endpoints included complete hematologic response (CHR), changes in JAK2V617F allele burden, and safety.
RESULTS: Among 42 patients, Ropeg significantly reduced mean phlebotomy frequency per year from 3.0 to 0.5 (p < 0.05) and improved CHR rates (69.1% at 48 weeks). The JAK2V617F allele burden decreased, and hydroxyurea-naïve patients showed better responses. The most frequently reported treatment-related adverse events included elevated liver enzymes and alopecia. Most adverse events were mild or moderate, with no grade 4 or 5 events reported.
CONCLUSION: These findings suggest that Ropeg is a promising treatment option for low-risk PV by effectively reducing the need for phlebotomy and demonstrating efficacy and safety.